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NCT05735444Recruiting

Prospective National Multi-center Registry of Obstructive Sleep Apnea Syndrome in Hypertensive Patients in China

Screening, Diagnosis and Treatment of Obstructive Sleep Apnea Syndrome in Hypertensive Patients in China: A Prospective National Multi-center Registry

Source: ClinicalTrials.gov · Last updated 21 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Study name: Screening, Diagnosis and Treatment of Obstructive Sleep Apnea Syndrome in Hypertensive Patients in China: A Prospective National Multi-center Registry. Rationale: Obstructive sleep apnoea syndrome (OSAS) is a common secondary cause of hypertension and significantly correlated with the risk of cardiovascular and cerebrovascular diseases. However, continuous positive airway pressure (CPAP) only shows modest blood pressure lowering effect, although it is effective in the relieve of daytime sleepiness and other symptoms of OSAS. One of the possible reasons for the low antihypertensive efficacy might be the low adherence to CPAP therapy. Nonetheless, few studies systematically investigated CPAP adherence with regard to its prediction and clinical relevance for cardiovascular protection and prevention. Objective: 1) To evaluate short- and long-term CPAP adherence in patients with hypertension and obstructive sleep apnea syndrome; 2) To investigate the predictors of short- and long-term CPAP adherence; 3) To explore the correlation between the CPAP adherence and blood pressure, target organ damage and the incidence of cardiovascular and cerebrovascular events. Study design: Prospective, multi-center, observational study. Study population: Patients with hypertension who are suspected to have obstructive sleep apnea syndrome due to snoring, daytime sleepiness and other related symptoms are considered eligible and should meet the following criterias: 1) Agree to participate in the study and sign the informed consent; 2) At least 18 years old; 3) STOP-Bang questionnaire, score ≥3 points; 4) Complete polysomnography in hospital; 5) Currently on CPAP therapy. Follow up: 3, 6 and 12 months after registry. Sample size estimation: At least 633 patients. Timeline: Start of subjects' enrollment: Jan 2023; End of subjects' enrollment: December 2026; End of study: December 2026. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Status (registry)
Recruiting
Study type
Observational
Enrollment
633 (estimated)
First submitted
31 Jan 2023
Start date
1 Jan 2023
Primary completion date
Dec 2026
Lead sponsor
Shanghai Jiao Tong University School of Medicine
NCT number
NCT05735444

What you commit to

  • Study type: Observational
  • Planned participants: 633
  • From 1 Jan 2023 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous or current treatment for OSAS without CPAP;
  • Intolerance of CPAP therapy;

Other illness

  • Severe respiratory diseases such as chronic obstructive pulmonary disease, or contraindications to CPAP therapy, such as pneumothorax, pulmonary bulla and new-onset stroke;
  • Sleep disorders or insomnia;

Other

  • Clinic systolic/diastolic blood pressure ≥180/110 mmHg;
  • Patient with cognitive dysfunction who are unable to provide informed consent;
  • Other circumstances that patients are not appropriate for the study upon the investigator's judgment.

Who the study is looking for

  • Agree to participate in the study and sign the informed consent;
  • At least 18 years old;
  • STOP-Bang questionnaire, score ≥3 points;
  • Complete polysomnography in hospital;
  • Currently on CPAP therapy.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.